BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    TTBIO EVOCLEAN Ultrasonic Scaler

    K Number: K201317 · Decision Dec 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    6
    Review Days
    200

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    Basic Information

    Device Name
    TTBIO EVOCLEAN Ultrasonic Scaler
    K Number
    K201317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ttbio Corp.
    Date Received
    May 18, 2020
    Decision Date
    December 4, 2020
    Product Code
    ELC
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ELC Scaler, Ultrasonic

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    K Number Device Name
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